Latest GHS Classification Results by the Japanese Government (edited by NITE)

Japanese



GENERAL INFORMATION
 
Item Information
CAS RN 540-73-8
Chemical Name 1,2-Dimethylhydrazine
Substance ID m-nite-540-73-8_v1
Download of Excel format Excel file

REFERENCE INFORMATION
Item Information
Guidance used for the classification (External link) To Guidance List
UN GHS document (External link) To UN GHS document
FAQ(GHS classification results by the Japanese Government) To FAQ
List of Information Sources (Excel file) List of Information Sources
List of Definitions/Abbreviations Definitions/Abbreviations
Sample Label by MHLW (External link) To Workplace Safety Site (MHLW)
Sample SDS by MHLW (External link) To Workplace Safety Site (MHLW)
OECD/eChemPortal (External link) To OECD/eChemPortal (External link)

PHYSICAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification Classification year (FY) GHS Classification Guidance for the Japanese Government
1 Explosives Classification not possible
-
-
- - There is a chemical group associated with explosive properties, neighboring nitrogen atoms, present in the molecule, but the classification is not possible due to no data. FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2 Flammable gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3 Aerosols Not classified (Not applicable)
-
-
- - Not aerosol products. It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Oxidizing gases Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5 Gases under pressure Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6 Flammable liquids Category 2


Danger
H225 P303+P361+P353
P370+P378
P403+P235
P210
P233
P240
P241
P242
P243
P280
P501
It was classified in Category 2 based on a flash point of -17 deg C (closed cup) and a boiling point of 81 deg C (both, Hommel (1991)). FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7 Flammable solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8 Self-reactive substances and mixtures Classification not possible
-
-
- - There is a chemical group associated with explosive properties, neighboring nitrogen atoms, present in the molecule, but the classification is not possible due to no data. FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9 Pyrophoric liquids Not classified
-
-
- - Because it is classified in Division 6.1, Subsidiary Risk 3, PG I in UNRTDG (UN2382), and it is considered to be not applicable to a pyrophoric substance, hazards of the highest precedence, it was classified as "Not classified." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10 Pyrophoric solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11 Self-heating substances and mixtures Classification not possible
-
-
- - Classification is not possible because test methods applicable to liquid substances are not available. FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12 Substances and mixtures which, in contact with water, emit flammable gases Not classified (Not applicable)
-
-
- - The chemical structure of the substance does not contain metals or metalloids (B, Si, P, Ge, As, Se, Sn, Sb, Te, Bi, Po, At). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
13 Oxidizing liquids Not classified (Not applicable)
-
-
- - Organic compounds containing no oxygen, fluorine or chlorine. It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
14 Oxidizing solids Not classified (Not applicable)
-
-
- - Liquid (GHS definition). It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
15 Organic peroxides Not classified (Not applicable)
-
-
- - Organic compounds containing no bivalent -O-O- structure in the molecule. It was classified as "Not classified (Not applicable)." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
16 Corrosive to metals Classification not possible
-
-
- - No data available. FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
17 Desensitized explosives Not classified
-
-
- - There are no chemical groups associated with explosive properties present in the molecule. It was classified as "Not classified." FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

HEALTH HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification Classification year (FY) GHS Classification Guidance for the Japanese Government
1 Acute toxicity (Oral) Category 3


Danger
H301 P301+P310
P264
P270
P321
P330
P405
P501
[Rationale for the Classification]
Based on (1), it was classified in Category 3.
Besides, though it would be classified in Category 2 based on data on mice in (2) and (3), data on rats were given precedence according to the GHS Classification Guidance for the Japanese Government.

[Evidence Data]
(1) LD50 for rats: 100 mg/kg (PATTY (6th, 2012), HSDB (Access on June 2019))

[Reference Data, etc.]
(2) LD50 for mice: male: 26 mg/kg, female: 60 mg/kg (ATSDR (1997))
(3) LD50 for mice: 36 mg/kg (PATTY (6th, 2012))
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Dermal) Category 3


Danger
H311 P302+P352
P361+P364
P280
P312
P321
P405
P501
[Rationale for the Classification]
Based on (1), it was classified in Category 3.
Besides, though it would be classified in Category 2 based on data on guinea pigs in (2), data on rabbits were given precedence in accordance with the GHS Classification Guidance for the Japanese Government.

[Evidence Data]
(1) LD50 for rabbits: 467 mg/kg (ATSDR (1997))

[Reference Data, etc.]
(2) LD50 for guinea pigs: 131 mg/kg (ATSDR (1997))
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Gases) Not classified (Not applicable)
-
-
- - [Rationale for the Classification]
Liquid (GHS definition). It was classified as "Not classified (Not applicable)."
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Vapours) Category 2


Danger
H330 P304+P340
P403+P233
P260
P271
P284
P310
P320
P405
P501
[Rationale for the Classification]
Based on (1) and (2), it was classified in Category 2.
Besides, since the LC50 value was lower than the 90% of the saturated vapor concentration (91,981 ppm), the reference value in units of ppm was applied as a vapour without a mist.

[Evidence Data]
(1) LC50 for rats (4 hours): 280-400 ppm (ATSDR (1997))
(2) LC50 for rats (4 hours): 280 ppm (HSDB (Access on June 2019))
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
1 Acute toxicity (Inhalation: Dusts and mists) Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
2 Skin corrosion/irritation Category 1


Danger
H314 P301+P330+P331
P303+P361+P353
P305+P351+P338
P304+P340
P260
P264
P280
P310
P321
P363
P405
P501
[Rationale for the Classification]
Based on (1), it was classified in Category 1.

[Evidence Data]
(1) This substance is strongly alkaline, so it is considered to be corrosive and irritating to the skin, eyes, and mucous membranes (PATTY (6th, 2012)).

[Reference Data, etc.]
(2) There is a description that contact with this substance may cause irritation to the skin, eyes, and mucous membranes (HSDB (Access on June 2019)).
(3) Dermal discoloration and irritation were observed in dogs, rabbits and guinea pigs on dermal exposure to this substance (ATSDR (1997)).
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
3 Serious eye damage/eye irritation Category 1


Danger
H318 P305+P351+P338
P280
P310
[Rationale for the Classification]
Based on (1) and (2), it was classified in Category 1.

[Evidence Data]
(1) This substance is classified in Category 1 in skin corrosion/irritation.
(2) This substance is strongly alkaline, so it is considered to be corrosive and irritating to the skin, eyes, and mucous membranes (PATTY (6th, 2012)).

[Reference Data, etc.]
(3) There is a report that conjunctivitis and erythema in the eyelids occurred when 3 microL of this substance was administered to the eyes of rabbits (ATSDR (1997)).
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Respiratory sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
4 Skin sensitization Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
5 Germ cell mutagenicity Category 2


Warning
H341 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on (1) and (2), it was classified in Category 2.

[Evidence Data]
(1) As for in vivo, the results were positive in a micronucleus test, a chromosomal aberration test, a DNA damage test, a DNA adduct formation test, a sister chromatid exchange test, and an unscheduled DNA synthesis test with mice and rats (ATSDR (1997), IARC 71 (1999)).
(2) As for in vitro, the result was positive in a mutation test with cultured human cells. There are negative and positive results in mouse lymphoma assays and bacterial reverse mutation tests (same as above).
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
6 Carcinogenicity Category 1B


Danger
H350 P308+P313
P201
P202
P280
P405
P501
[Rationale for the Classification]
Based on the classification results by other organizations in (1), it was classified in Category 1B in accordance with the GHS Classification Guidance for the Japanese Government.

[Evidence Data]
(1) As for classification results by domestic and international organizations, it was classified in Group 2A by IARC because of evidence for genotoxicity as the mechanism of carcinogenic action, in addition to sufficient evidence of carcinogenicity in experimental animals (IARC 71 (1999)). It was also classified in Carc.1B by the EU (ECHA C&L Inventory (Access on June 2019)).

[Reference Data, etc.]
(2) As for experimental animals, many carcinogenicity tests with rats and mice, mainly by subcutaneous, infrequently by oral and other routes (intraperitoneal, etc.) were conducted. Whatever the route of administration, this substance produced a high incidence of adenomas and adenocarcinomas of the colon and to a lesser extent of adenomas and adenocarcinomas of the small bowel. In tests given with drinking water or by gavage, vascular tumours were observed in a high incidence (IARC 71 (1999)).
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
7 Reproductive toxicity Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.

[Reference Data, etc.]
(1) In a developmental toxicity test with female hamsters dosed by the oral route on day 12 of gestation, no developmental toxicity or teratogenicity was observed (ATSDR (1997)). This test was a limited test in which administration was of only one dosage for one day during the gestational period.
(2) In a developmental toxicity test with female rats dosed intraperitoneally on days 6-15 of gestation, decreased body weight gain of maternal animals, decreased body weight of fetuses and slightly increased malformations were observed (IARC 71 (1999), PATTY (6th, 2012)). Since this test was conducted by intraperitoneal dose, it was not adopted as evidence of the classification.
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
8 Specific target organ toxicity - Single exposure Category 3 (Respiratory tract irritation)


Warning
H335 P304+P340
P403+P233
P261
P271
P312
P405
P501
[Rationale for the Classification]
Based on (1), since it was considered to show respiratory tract irritation in inhalation exposure, it was classified in Category 3 (respiratory tract irritation).

[Evidence Data]
(1) This substance is strongly alkaline, so it is considered highly corrosive and irritating to the skin, eyes, and mucous membranes (PATTY (6th, 2012)).

[Reference Data, etc.]
(2) There is a report that, when male dogs were dosed by the oral route at 60 mg/kg/day once per week for 2 weeks, for a total of 2 times, 2/2 animals died and hepatic degeneration and hemorrhagic necrosis were observed (ATSDR (1997)).
(3) Though there is no information on the route and dosage of the exposure and the details are unknown, there is a description that convulsions are caused by overexposure to this substance (PATTY (6th, 2012)).
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
9 Specific target organ toxicity - Repeated exposure Category 1 (liver, heart, kidney)


Danger
H372 P260
P264
P270
P314
P501
[Rationale for the Classification]
Based on (1) and (2), it was classified in Category 1 (liver, heart, kidney).

[Evidence Data]
(1) In a test in which mice were dosed by feeding for 5 months, mild hepatitis was observed at 0.75 mg/kg/day (within the range for Category 1), focal myocytolysis, fibrosis, calcification of the heart, hepatitis, hepatocellular necrosis, hepatocellular hypertrophy, interstitial nephritis and pyelonephritis were observed at 1.6 mg/kg/day (within the range for Category 1) were observed (ATSDR (1997)).
(2) Other than (1), in a test in which mice were dosed by feeding for 6 weeks, in a test in which dogs were dosed by gavage for 4 to 10 weeks (once per week) and in a test in which guinea pigs were dosed by gavage for 7 to 10 weeks (once per week), the effects on the liver were reported at all of the doses which correspond to Category 1 when converted to the guidance value (ATSDR (1997)).
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
10 Aspiration hazard Classification not possible
-
-
- - [Rationale for the Classification]
Classification not possible due to lack of data.
FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))

ENVIRONMENTAL HAZARDS
Hazard class Classification Pictogram
Signal word
Hazard statement
(code)
Precautionary statement
(code)
Rationale for the classification Classification year (FY) GHS Classification Guidance for the Japanese Government
11 Hazardous to the aquatic environment Short term (Acute) Classification not possible
-
-
- - Classification not possible due to lack of data. FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
11 Hazardous to the aquatic environment Long term (Chronic) Classification not possible
-
-
- - Classification not possible due to lack of data. FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))
12 Hazardous to the ozone layer Classification not possible
-
-
- - Classification not possible due to lack of data. FY2019 GHS Classification Guidance for the Japanese Government (FY2013 revised edition (Ver. 1.1))


NOTE:
  • GHS Classification Result by the Japanese Government is intended to provide a reference for preparing a GHS label or SDS for users. To include the same classification result in a label or SDS for Japan is NOT mandatory.
  • Users can cite or copy this classification result when preparing a GHS label or SDS. Please be aware, however, that the responsibility for a label or SDS prepared by citing or copying this classification result lies with users.
  • This GHS classification was conducted based on the information sources and the guidance for classification and judgement which are described in the GHS Classification Guidance for the Japanese Government etc. Using other literature, test results etc. as evidence and including different content from this classification result in a label or SDS are allowed.
  • Hazard statement and precautionary statement will show by hovering the mouse cursor over a code in the column of "Hazard statement" and "Precautionary statement," respectively. In the excel file, both the codes and statements are provided.
  • A blank or "-" in the column of "Classification" denotes that a classification for the hazard class was not conducted in the year.
  • An asterisk “*” in the column of “Classification” denotes that “Not classified (or No applicable)” and/or “Classification not possible” is applicable. Details are described in the column of “Rationale for the classification”. If no English translation is available for “Rationale for the classification,” please refer to the Japanese version of the results.

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